QUICK ANSWER · AEO / GEO
A mitochondrial-derived peptide with mainly preclinical and early human research; metabolic findings remain investigational.
ENTITY FACTS
What should readers identify first?
What remains unknown?
- safety, pharmacokinetics, pharmacodynamics and dose-response in humans
- whether NCT07505745 will demonstrate benefit or identify adverse effects
- whether exogenous MOTS-c reaches pharmacologically active concentrations in humans
- the molecular target or targets and which organs may be affected
- long-term immunogenicity, reproductive and carcinogenicity risks
- identity, purity and comparability of products using the MOTS-c name
- current Thailand, EU and UK marketing-authorisation status pending direct local verification
What limits these conclusions?
- The field combines distinct evidence types: endogenous peptide measurements in humans, mechanistic cell work, administered peptide in rodents and a recruiting human trial without results. These cannot be pooled as if they were one clinical evidence base. FDA's July 2026 briefing predates completion of NCT07505745 and found no human administration data usable for its safety/effectiveness review.
This overview does not replace the detailed adverse-event and product-specific risk discussion in the complete Thai profile or the original sources.
EVIDENCE BOUNDARY
What this overview does not establish
- An evidence grade does not rank this molecule against another treatment.
- A molecule name does not establish the identity, purity or regulatory status of a product.
- Animal, cell or biomarker findings do not automatically establish human clinical benefit.
- Approval in one country or indication does not transfer globally.
Where can I check the evidence?
Original sources from the same evidence record used by Compare. Read each source's population, methods, limitations and date; a citation is not product endorsement.
- https://www.fda.gov/media/193347/download
- https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
- https://clinicaltrials.gov/study/NCT07505745
- https://pubmed.ncbi.nlm.nih.gov/25738459/
- https://pubmed.ncbi.nlm.nih.gov/33473109/
- https://pubmed.ncbi.nlm.nih.gov/34351816/
- https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
- https://products.mhra.gov.uk/
FAQ · ANSWER ENGINE
Frequently asked questions
What is MOTS-c?
MOTS-c is described pharmacologically as Mitochondrial-derived 16-amino-acid peptide under clinical investigation. A mitochondrial-derived peptide with mainly preclinical and early human research; metabolic findings remain investigational.
Does MOTS-c have strong evidence?
PrimeCoreBio records Evidence Grade E. This grade describes evidence strength, not comparative effectiveness or suitability for an individual.
Is MOTS-c approved everywhere?
No global conclusion should be inferred. PrimeCore Class B must be read with the exact product, country and indication on the source-rich profile.
Educational information only. This page does not provide diagnosis, treatment, prescribing, dosage, injection instructions or individual medical advice.